A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Risk of Iron Deficiency and Anaemia in African Children (FERROUS 3)

Danone

Status: Completed

Conditions: Iron Deficiencies

Treatments: Diagnostic Test: Standard blood test; Other: Imaging and videography of anatomical sites

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07186205

24REX0083183

Details and patient eligibility

About

An exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in African children

Full description

This is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against standard venous blood sampling. Images and/or videos will be collected by healthcare professionals, together with blood test results. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.

Enrollment: 126 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children over 6 months of age and under 6 years of age.
• Written consent from the legally acceptable parent(s) or representative(s), who are themselves ≥ 18 years of age, to consent to and comply with the terms and conditions of the study.
• The parent(s) must be able to understand the content of the study and complete the study questionnaires.
• Parents should be comfortable with their child having blood drawn.
• The participant must have a haemoglobin level corresponding to a haemoglobin group with open slots for participation.

Exclusion criteria

• Children with a medical condition that, in the opinion of the investigator, would render them unsuitable for enrolment
• Children with nail bed obstructions, nail polish, nail discoloration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, or lip pigmentation due to thyroid dysfunction (e.g., Peutz-Jeghers syndrome)
• Children who are unable to cooperate with study procedures
• Employees and/or children/family members or parents of employees of the Danone Global Research & Innovation Center or Danone affiliates participating sites
• Children whose health condition requires emergency care

Trial design

126 participants in 1 patient group

Children aged 6-72 months of age

Description:

Approximately 120 children aged above 6 months old and below 6 years of age across potential study sites. Subjects will be grouped by haemoglobin (Hb) level ranging from \<6 g/dL to ≥ 14.0 g/dL.

Treatment:

Other: Imaging and videography of anatomical sites

Diagnostic Test: Standard blood test